Events

Safety Alert for Emergency Lavoptik flushing flasks, face and body: (1) 16 oz., (2) 32 oz .; Lavoptik Concentrated Eye Wash Bottles: (3) 70 oz., (4) 180 oz .; Rapid Clear Eye Wash Bottles: (5) 16 oz., (6) 32 oz., (7) 128 oz .; (8) 6 oz. Lavoptik eye wash bottles; (9) 16 oz. Zee saline solution flasks; (10) 180 oz Rapid Clear Concentrated Eye Wash Bottles; (11) 5 qt. Zee Protector II (Zee Protector II Refill Eyewash Solution Bottles) Refill Bottle

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by H L Bouton Co.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    209
  • Date
    2000-11-17
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Extra notes in the data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    The manufacturer has removed these products because of improper labeling. at this point the manufacturer is removing the vials above because they may be contaminated with an aggressive biological agent in the eyes. the company did not provide any information to ecri.
  • Action
    Make sure you have been contacted by HL Bouton. Identify and collect any affected product from your inventory. Discontinue use and dispose of the product, return any affected product to HL Bouton by mail to the address. For more information contact your local representative or directly with HL Bouton at 1 (508) 759-8000 in the United States.

Device

Emergency Lavoptik flushing flasks, face and body: (1) 16 oz., (2) 32 oz .; Lavoptik Concentrated...

Manufacturer

H L Bouton Co
  • Source
    ANVSANVISA